Talquetamab

TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). TALVEY is a bispecific GPRC5D-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Talquetamab-tgvs is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as healthy tissues such as epithelial cells in keratinized tissues of the skin and tongue. In vitro, talquetamab-tgvs activated T-cells caused the release of proinflammatory cytokines and resulted in the lysis of multiple myeloma cells. Talquetamab-tgvs had anti-tumor activity in mouse models of multiple myeloma.

For subcutaneous injection. Patients should be hospitalized for 48 hours after all doses within the step-up dosing schedule. Administer pretreatment medications as recommended. See Full Prescribing Information for instructions on preparation and administration. TALVEY Weekly Dosing Schedule. Dosing schedule Day Dose Based on actual body weight. Step-up dosing schedule Day 1 Step-up dose 1 0.01 mg/kg Day 4 Dose may be administered between 2 to 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions. Step-up dose 2 0.06 mg/kg Day 7 First treatment dose 0.4 mg/kg Weekly dosing schedule One week after first treatment dose and weekly thereafter Maintain a minimum of 6 days between weekly doses. Subsequent treatment doses 0.4 mg/kg once weekly TALVEY Biweekly (Every 2 Weeks) Dosing Schedule.

None. None.

Boxed warning (cytokine release syndrome and neurologic toxicity): including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity. Oral Toxicity and Weight Loss: Monitor for oral toxicity and weight loss. Withhold or permanently discontinue based on severity. Infections: Can cause serious, life-threatening, or fatal infections. Monitor for signs and symptoms of infection, treat appropriately. Withhold or consider permanent discontinuation based on severity. Cytopenias: Monitor complete blood counts. Skin Toxicity: Monitor for skin toxicity, including rash progression, for early intervention and treat appropriately.

The following adverse reactions are also described elsewhere in the labeling: Cytokine Release Syndrome Neurologic Toxicity, including ICANS Oral Toxicity and Weight Loss Infections Cytopenias Skin Toxicity Hepatotoxicity The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache. The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased.

For certain cytochrome P450 (CYP) substrates, minimal changes in the substrate concentration may lead to serious adverse reactions. Monitor for toxicity or drug concentrations of such CYP substrates when co-administered with TALVEY. Talquetamab-tgvs causes release of cytokines that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. Increased exposure of CYP substrates is more likely to occur from initiation of the TALVEY step-up dosing schedule up to 14 days after the first treatment dose and during and after CRS.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.